KR102593376B1 - Apparatus and method for cannulation of vascular access grafts - Google Patents

Abstract

The present invention relates to a device for guiding cannula insertion into a dialysis needle of an arteriovenous dialysis access graft implanted subcutaneously in a subject's body. This guiding device includes a base portion ending in a longitudinal edge, a pocket having a longitudinal dimension and a lateral dimension configured to receive a body member, the distance between the longitudinal edges of the base portion being substantially equal to the lateral dimension of the ace grafts. Includes an elongated tubular sleeve as specified. The body member is adapted to be received in a pocket of the sleeve for securing adjacent a subcutaneous access graft such that the interior surface of the base is aligned with the cannula insertion point of the graft to guide the position of needle insertion.

Description

Apparatus and method for cannulation of vascular access grafts

cross-reference

This application is related to U.S. Provisional Application No. 62/479,791, filed March 31, 2017, and entitled “APPARATUS AND METHOD FOR CANNULATION OF VASCULAR ACCESS GRAFT” by Shawn M. Gage and Jeffrey H. Lawson as inventors. The contents of this provisional application are incorporated herein by reference in their entirety, and the benefit of the filing date of the provisional application is asserted for all purposes lawfully served by such claims.

Devices and methods for needle access of surgically created vascular accesses for use as a means of accommodating hemodialysis and other procedures requiring vascular access are described, and more specifically, for needle access after implantation. A device and method for synovial access of an arteriovenous fistula or arteriovenous graft allowing positioning of cannula insertion sites are described.

Hemodialysis is a life-sustaining treatment for patients with end-stage renal disease. Hemodialysis is a process in which large amounts of blood are removed from the body, filtered through a machine to remove waste, and then returned to the body.

A vascular access site on the body from which blood is removed and returned during dialysis is established before hemodialysis begins. The creation of an arteriovenous fistula (“AVF”) is a surgical procedure in which a vein is connected directly to an artery. The connection between the artery and vein can be formed using an arteriovenous graft (“AVG”), which is made of synthetic material and implanted just under the skin. Deployment sites for AVGs include, but are not limited to, the forearm, upper arm, neck, chest and thighs in straight or loop configurations. Once surgically placed, the AVG becomes a conduit that can be used repeatedly for blood access during hemodialysis. A needle is used to puncture the wall of the graft directly by inserting a cannula into the graft through the skin. In conventional hemodialysis, two cannulae are placed on the access graft, one needle puncture being made into the graft wall on the arterial side and the other needle puncturing being made on the venous side. During dialysis, blood is withdrawn from the arterial side of the graft, passes through a hemodialyzer, and then returned to the patient through a second needle inserted into the venous side of the graft.

A critical step in the hemodialysis procedure is “finding” the appropriate location within the graft to perform needle sticks. Moreover, conventional dialysis protocols require patients to undergo dialysis procedures at least three times a week. As a result, the skin and underlying tissue are punctured several times each week to gain access to the implanted AVG. The technique of cannulating an AVF or AVG for hemodialysis requires considerable skill. Vascular accesses are often several centimeters below the skin surface and cannot be found by visual inspection. The medical technologist must locate the AVF or AVG by palpation, which can be very difficult. Perforation of vascular access is prone to errors and complications. Incorrect puncture may promote access rupture, bleeding, hematoma formation, pseudo-aneurysm formation, severe pain, or the development of an organized thrombus within the lumen of the graft. The formation of these thrombi may not only result in multiple graft thrombi but also ultimately lead to graft failure. There are two contraindications that adversely affect the time the graft will remain open if the vascular access of the needle is not fully or improperly placed within the lumen of the AVF or AVG device. Simply finding the area to insert a cannula using the conventional method of palpating through the skin is sometimes unreliable.

For the foregoing reasons, a need exists for a device and method for proper cannulation of a vascular access graft or fistula, including accurate identification of the access area of the vascular access after transplantation. The new device allows the user of the vascular access to facilitate accurate and reproducible entry of dialysis needles, cannulas, etc. into the implanted AVF or AVG that are introduced into the vascular access by insertion through the skin, thus allowing the implanted AVF or AVG device. Access must be improved.

A device is provided for guiding cannulation into a dialysis needle of an arteriovenous dialysis access graft implanted subcutaneously in a subject's body. An arteriovenous dialysis graft includes a flexible conduit defining a longitudinal flow passage, a first end configured to be connected to an artery of a subject and a vein of the subject to allow blood to flow from the first end through the longitudinal flow passage of the conduit. It has a second end configured to flow to the second end. The cannula insertion chamber defines a cannula insertion port, and a conduit extends through the cannula insertion chamber to receive a needle inserted through the cannula insertion port. The guiding device includes an elongated body member having a longitudinal axis and an interior surface. The body member includes a base portion ending in longitudinal edges. The distance between the longitudinal edges of the base portion is substantially equal to the lateral dimension of the cannula insertion chamber. The legs extend from the longitudinal edges of the base portion, and the legs terminate at the longitudinal edges. The base and legs form an open longitudinal channel for receiving the cannula insertion chamber. The body member is secured adjacent to the subcutaneous cannula insertion chamber, such that the legs guide the position of inserting the needle through the body member and into the cannula insertion chamber, and the legs are positioned to align the inner surface of the base with the cannula insertion port. Operablely engaged with the cannula insertion chamber.

In one aspect, the body member has a first end and a second end, where the body member extends from the first end to the second end of the cannulation chamber. This body member may have at least one passage opening that opens into the interior surface of the body member to allow passage of the needle.

In another aspect, at least a portion of the cannula insertion chamber and body member comprise a substantially magnetic or paramagnetic material.

In another aspect, a device is provided for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft implanted subcutaneously in a subject's body. The arteriovenous dialysis graft has a first end configured to form a longitudinal flow passage and connected to an artery of the subject and a first end configured to be connected to a vein of the subject such that blood flows from the first end to the second end through the longitudinal flow passage of the conduit. It includes a flexible conduit having two ends. The cannula insertion chamber defines a cannula insertion port between the first end and the second end, and the conduit extends through the cannula insertion chamber to receive a needle inserted through the cannula insertion port. The guiding device includes an elongated tubular sleeve with a longitudinal axis. This sleeve defines an opening with longitudinal and lateral dimensions adapted to be substantially equal to the longitudinal and lateral dimensions of the cannula insertion chamber. The sleeve is configured to receive the subject's body adjacent the subcutaneous cannulation chamber of the access graft such that the opening surrounds the cannula insertion chamber to guide the position of needle insertion into the cannula insertion port.

In one aspect, the material of the sleeve is selected from film, paper, woven or non-woven.

In another embodiment, a device is provided for guiding cannulation into a dialysis needle of an arteriovenous dialysis access graft implanted subcutaneously in a subject's body. The arteriovenous dialysis graft has a first end configured to form a longitudinal flow passage and connected to an artery of the subject and a first end configured to be connected to a vein of the subject such that blood flows from the first end to the second end through the longitudinal flow passage of the conduit. It includes a flexible conduit having two ends. The cannula insertion chamber defines a cannula insertion port between the first end and the second end. A conduit extends through the cannula insertion chamber to receive a needle inserted through the cannula insertion port. The guiding device includes an elongated body member having a longitudinal axis and an interior surface. This body member includes a base portion terminated with longitudinal edges, the distance between the longitudinal edges of which base portion being substantially equal to the lateral dimension of the cannula insertion chamber. The elongated tubular sleeve has a longitudinal axis, and the sleeve defines a pocket having longitudinal and lateral dimensions configured to receive the body member. The body member is configured to be received in a pocket of the sleeve for securing adjacent to the subcutaneous cannula insertion chamber such that the interior surface of the base portion is aligned with the cannula insertion port to guide the position of inserting the needle through the body member and into the cannula insertion chamber. do.

Also provided is a kit that includes at least one dialysis needle for accessing an arteriovenous dialysis access graft implanted subcutaneously in a subject's body. The arteriovenous dialysis graft forms a longitudinal flow passage and is configured to connect a first end to an artery of the subject and to a vein of the subject, such that blood flows from the first end to the second end through the longitudinal flow passage of the conduit. and a flexible conduit having a second end. The cannula insertion chamber defines a cannula insertion port, and a conduit extends through the cannula insertion chamber to receive a needle inserted through the cannula insertion port. A dispenser is provided for receiving a plurality of elongated body members, each body member having a longitudinal axis and an inner surface. The body member includes a base portion terminated with longitudinal edges, the distance between the longitudinal edges of the base portion being substantially equal to the lateral dimension of the cannulation chamber. The body member is secured adjacent to the subcutaneous cannula insertion chamber such that the legs operatively engage the cannula insertion chamber to align the interior surface of the base portion with the cannula insertion port to guide the position of needle insertion. Each body member has at least one passageway opening that opens into an interior surface of the body member for passage of a needle, the needle passageway of the body member being at a different location than the needle passageway of any other body member.

For a more complete understanding of the present invention, reference is now made to the embodiments shown in the accompanying drawings and described below.
1 is an exploded perspective view of one embodiment of an applicator device for cannulation of an arteriovenous graft including a cannulation chamber.
Figure 2 is a longitudinal cross-sectional view of the applicator device as shown in Figure 1 in position in a subcutaneous cannula insertion chamber.
Figure 3 shows a top perspective view, a bottom perspective view, a measured side view, a front end view, and a top and bottom view of the applicator device as shown in Figure 1.
Figure 4 is a top perspective view, bottom perspective view, measured side view, front end view, and top and bottom views of a second embodiment of an applicator device for cannulation of an arteriovenous graft including the cannulation chamber shown in Figure 1.
Figure 5A is a perspective view of one embodiment of a portion of an arteriovenous graft including a cannulation chamber.
Figure 5B is an exploded perspective view of a third embodiment of an applicator device for cannulation of an arteriovenous graft comprising a cannulation chamber as shown in Figure 5A.
Figure 6 is a perspective view of a plurality of applicator devices having sequentially spaced needle passages.
Figure 7 is a perspective view of a plurality of applicator devices as shown in Figure 6 with needle passages offset diagonally through the applicator devices.
8A and 8B are perspective views of a dispensing cartridge for packaged applicator devices.
Figure 9 is a top view of one embodiment of a pair of adhesive applicator devices for guiding cannulation of an arteriovenous graft comprising a pair of cannulation chambers.
Figure 10 is a top view of a pair of adhesive applicator devices as shown in Figure 9 in position on the arm containing a subcutaneous arteriovenous graft comprising a pair of cannula insertion chambers.
11A and 11B are perspective views of a fourth embodiment of an applicator device and sleeve for cannulation of an arteriovenous graft;
Figure 12 is a top view of one embodiment of an adhesive applicator device for guiding cannulation of a subcutaneous arteriovenous graft, each including a pair of cannulation chambers (not shown) for performing hemodialysis.
Figure 13 is a top view of one embodiment of a frangible adhesive applicator for guiding cannulation of a subcutaneous arteriovenous graft, each including a pair of cannulation chambers shown as phantoms.
Figure 14 is a top view of another embodiment of a frangible adhesive applicator for guiding cannulation of a subcutaneous arteriovenous graft, each including a pair of cannulation chambers shown as phantoms.
15A and 15B are perspective and front views of a flexible strap for use in cannulating a subcutaneous arteriovenous graft.
Figure 16 is a top view of a pair of straps as shown in Figures 15A and 15B in place of an applicator device on the arm to guide cannulation of a subcutaneous arteriovenous graft (not shown).
Figure 17 is a top view of a pair of straps as shown in Figures 15A and 15B in place on the arm to guide cannulation of a subcutaneous arteriovenous graft, each containing a pair of cannulation chambers shown as phantoms; .
Figure 18 is a top view of one embodiment of a sleeve in place on the arm for guiding cannulation of a subcutaneous arteriovenous graft, each containing a pair of cannulation chambers shown as phantoms.
Figure 19 is an up close perspective view of the sleeve as shown in Figure 18 showing a pocket containing an applicator device for guiding cannulation of a subcutaneous arteriovenous graft.
Figure 20 is perspective views of a sleeve as shown in Figure 18 including an applicator device.

As used herein, the term “vascular access” is used to mean an intended surgical connection between the arterial and venous systems through which blood flows from an artery to a vein. As noted above, this can be achieved by connecting a vein directly to an artery (AVF) or utilizing a synthetic or autograft conduit to connect the arterial and venous systems (AVG). Since there are many types of AVGs and associated components that are known in the art and can be utilized to practice the present invention, a more detailed description of these components is not required. It is understood that the present invention does not relate to any particular type of AVG. The vascular access graft devices and methods described herein are for use in medical procedures requiring vascular access. Accordingly, the features described herein can be utilized with any existing vascular access graft comprising AVGs, including but not limited to the AVG described by U.S. Pat. No. 9,585,998, which is incorporated herein by reference in its entirety. can be used A similar application is also shown and described in US Published Application No. 2014/0336682, which is incorporated herein by reference in its entirety. Accordingly, detailed descriptions of the functionality of all of the components and the use of the grafts are considered unnecessary for understanding the teachings of the invention by those skilled in the art.

For convenience, certain technical terms are used in this specification and should not be construed as limiting. For example, “upper”, “lower”, “left”, “right”, “horizontal”, “vertical”, “upward”, “ The terms "downward", "top", and "bottom" merely describe the configurations shown in the drawings. In practice, such components may be oriented in any direction, and therefore the term should be understood to include such variations unless otherwise specified. The words “interior” and “exterior” refer to directions toward and away from the geometric center of the core and its designated portions, respectively. Such technical terms include the words specifically mentioned above, their derivatives and words of similar meaning.

Referring now to the drawings where like reference numerals indicate corresponding or similar elements throughout the figures, a vascular access graft for connecting an artery to a vein is shown in Figure 1 and generally designated at 40. Vascular access graft 40 includes a tubular portion 42 of biocompatible material for guiding fluid, such as blood. As is typical, tubular portion 42 joins an artery at a first end and a vein at a second end (not shown). A pair of spaced apart cannulation chambers 44 are disposed midway along the length of the tubular portion in fluid communication with the arterial and venous sides of the vascular access graft 40 .

An applicator device for use in identifying a needle insertion location for cannulation of an implanted vascular access graft 40 is also shown in FIG. 1 and generally indicated at 50. The applicator device 50 may be adapted to the cannulation chamber 44 of the vascular access graft 40, allowing highly localized and precise delivery of the needle into a predetermined portion of the cannulation chamber 44. The term “adaptable” herein includes any corresponding fixation or alignment means for positioning the application device 50 relative to the cannula insertion chamber 44. It is therefore understood that a number of adaptations that can be used to align the applicator device to a wide range of vascular access grafts are envisaged.

The applicator device may be formed from synthetic or natural materials, including but not limited to thermoplastics, thermoset polymers, elastomers, rubber, or woven or non-woven composite materials. The applicator device may be of any suitable molded form, for example polymers, plastic foams (including open celled foams), woven or non-woven composites, mixtures thereof, etc. In particular, suitable applicator devices are, for example, nylon, polyolefins such as polyethylene, including UHMW polyethylene, polyetheretherketone (PEEK), polysulfone, polypropylene, ethylene propylene copolymers and ethylene butylene copolymers, polyurethanes, polyurethane foams. , polystyrene, plasticized polyvinyl chloride, polyester, Delrin polyacetal and polyamide, and structural plastics such as homopolymers and copolymers of the above. The applicator device may also be made of a gel-like material to provide pressure for hemostasis when compressed. The applicator may be doped with one or more drugs to aid the cannula insertion and/or needle removal process. For example, lidocaine may be added to help minimize needle stick pain and/or a topical hemostatic agent may be included to help stop bleeding. Many combinations of drug combinations with applicators can be envisioned. It is understood that the applicator device can take on a variety of shapes as needed to accommodate and adapt to a variety of vascular access grafts and cannulation chambers. It is further understood that a needle passage may be provided where the material of the applicator device is too difficult to allow penetration by a needle.

In one aspect, the applicator device 50 may be configured to adapt to the implanted vascular access graft 40 by fitting over the implanted graft in a puzzle piece manner. In this embodiment, the “fit-on” applicator device 50 as shown in FIG. 3 has a substantially oval profile and has a substantially major base portion 52 having a longitudinal axis. It is an elongated member containing. Base portion 52 spans between generally planar side walls 54 or legs, two of which depend on longitudinal edges on each side of base portion 52 . Legs 54 generally run vertically along the length of the edge of base portion 52. Each of the legs 54 terminates at longitudinal edges. Base portion 52 and legs 54 define an open longitudinal channel. 1 and 2, an applicator device 50 having this configuration has an upper peripheral rim 46 forming spaced apart notches 48 for receiving the legs 54 of the applicator device 50. ) is applicable to the AVG (40) including the cannula insertion chamber (44). In use, the applicator device 50 is adapted to the AVG 40 by positioning the device over the cannulation chamber 44 such that the legs 54 fit into the notches 48 with the skin captured between them. do. In this arrangement, the applicator device 50 indicates the location of the cannula insertion chamber 44 and the user can select a desired location along the length of the cannula insertion chamber for needle insertion.

Referring to Figure 2, in use, the vascular access graft is implanted under the patient's skin, with one end implanted in an artery and the other end in a vein to establish fluid continuity from the artery into the vein through the lumen of the tubular element. In a method of performing hemodialysis on a patient using a vascular access graft (40), the lumen of the vascular access graft (40) is exposed to a needle such that blood can be diverted from the lumen to the hemodiafiltration unit to be filtered and then returned to the lumen. It is connected to the hemodiafiltration unit via. It is understood that vascular access grafts may have uses other than dialysis. These uses include situations where the patient requires frequent intravascular injections or infusion of therapeutic fluids. In all cases, the use of applicator devices, stickers, straps and sleeves typically greatly reduces the number of “missed” needle sticks and identifies implanted devices that typically require needle cannulation. Promotes greater accuracy in

The applicator device 50 is manually aligned with the cannula insertion chamber 44 such that the legs 54 correspond to the notches 48 in the cannula insertion chamber 44 . The applicator device 50 is then pressed in a direction towards the cannula insertion chamber 44 so that the legs 54 engage in the notches 48 . During downward movement of the device 50, the legs 54 are slidably received in longitudinal notches 48 in the peripheral rim 46 of the cannula insertion chamber 44. Accordingly, applicator device 50 is positioned such that the device is positioned above cannulation chamber 44 as shown in FIG. 1 . The user then inserts one or more needles into the cannulation chamber 44 to begin hemodialysis. Needle insertion is facilitated so that the user can do so as quickly and accurately as possible with minimal blood loss and maximum benefit to the user.

Another embodiment of a “fin-on” applicator device is shown in FIG. 4 and is generally indicated at 60. As in the previous embodiment, the applicator device 60 is an elongated member with a substantially oval profile and includes a substantially main base portion 62 with a longitudinal axis. In this embodiment, base portion 62 defines spaced notches 64 formed along the longitudinal edges of each side of base portion 62. Applicator device 60 with this configuration can be inserted into a cannula with legs (not shown) projecting outwardly from the upper peripheral rim 46 for insertion into spaced notches 64 of applicator device 60. Applicable to AVG 40 including chamber 44. In use, the applicator device 60 is adapted to the AVG 40 by positioning the device over the cannulation chamber 44 such that the legs fit into the notches 64. In this arrangement, the applicator device 60 indicates the location of the cannula insertion chamber 44 and the user can then select the desired location along the length of the device for insertion of the needle.

In another embodiment, the vascular access graft 40 may include one or more fixedly positioned magnetic, paramagnetic, or Contains ferromagnetic materials (70). In the depicted embodiment, the magnetic or paramagnetic sites are arranged circumferentially along the peripheral rim 46 at the upper surface of the cannula insertion chamber 44. This arrangement substantially defines the boundaries of the port 47 of the cannula insertion chamber 44 configured to receive a needle prick. After injection, cannulation chamber 44 can be positioned within the patient's body by passing magnets over the patient's skin surface proximate to the injection site, whereby magnets 70 are used to prick the vascular access graft during cannulation. Alternatively, it allows essentially identifying the optimal location for needle access.

A locator or detector (not shown) comprising one or more magnets may be used to position the implanted graft and identify the cannulation chamber 44 for needle insertion and access. A locator or “wand” is passed over the skin suspected to be proximal to the implanted graft. The wand is then used to identify and position the cannulation chamber 44, or one or more areas within, on, or around the implanted graft where cannulation should optimally occur. This “localizing” ability of the magnet-containing detector makes it easier to find the appropriate cannulation site while minimizing damage to the vascular access graft. The cannula insertion chamber 44 can be localized through the skin with high accuracy and precision by passing the wand over the skin surface in the area proximal to the implant. This allows the user to perform needle insertion or cannula insertion at at least one selected location in the port 47 area as defined by the presence of one or more magnetic material portions. It is possible to extend this to applications for detecting implanted AVGs via RFID tags, concentrations of specific materials to be detected by near-infrared/visible spectroscopy, or other methods known in the art.

Although any suitable size magnet may be used, exemplary magnets include neodymium iron boron (NdFeB) cylindrical (e.g., “button”) magnets. In certain embodiments, the magnets may be coated with one or more protective layers to facilitate maximum protection and durability. Preferably, the paramagnetic material used in the formation of the disclosed medical devices includes or consists essentially of iron, steel, cobalt, nickel, ceramic materials, surgical-grade steel, or alloys or combinations thereof. It will be formed or composed of these. Alternatively, the material used in the formation of the disclosed medical devices comprises a superparamagnetic material, including, for example, superparamagnetic metal oxide nanoparticles (e.g., superparamagnetic iron oxide nanoparticles [SPIO]), It may essentially consist of or be composed of it [see Ye Kyondae, Ji et al. (2007)].

The number of magnet sites 70 spaced around the rim 46 of the cannula insertion chamber 44 may be any practical number. The vascular access graft is believed to include from 2 to about 8 or 10 magnetic sites arranged equidistantly along a substantial portion of the long axis of the graft 10. Exemplary magnets for use with the disclosed access devices, grafts and vascular access ports are preferably ceramic, lanthanoid, paramagnetic, ferrimagnetic or made of aluminum, boron, cobalt, copper, iron, neodymium, nickel, samarium, titanium. or those including, but not limited to, combinations or alloys thereof, including but not limited to commercially available permanent alloy magnets such as NdFeB, AlNi, AlCoMax, AINiCo, TiConAl, etc. It may comprise, consist essentially of, or alternatively be composed of ferromagnetic materials.

In use, the user places the detector “wand” on the skin over the implanted vascular access graft 40. Magnets on the wand detect and localize magnetic sites on the surface of the cannulation chamber 44 of the implanted vascular access graft. A needle, as identified by the wand, is inserted through the skin into port 47 of cannulation chamber 44. Localization and identification of the vascular access graft 40 after implantation is facilitated by the presence of one or more portions of magnetic material 70 included in the cannulation chamber 44.

In an alternative arrangement, a third embodiment of a fit-on applicator device is shown in FIG. 5B and is indicated generally at 80. In this embodiment, magnets 82 are provided on the inner peripheral surface of the applicator device 80 for alignment with magnets 70 on the rim 46 of the cannula insertion chamber 44. It is understood that the applicator device and subcutaneous implant may include other means for interaction in addition to or alternatively to magnets. This means of interaction may include sensors in the applicator device, AVG, or both. Sensors can interact with signal alignment, or a wand can be used as described above. The applicator device may include light for signaling. Subcutaneous cannulation chambers can also glow at certain wavelengths, such as infrared. The interaction may also be mechanical, such as an audible click when the applicator device and cannula insertion chamber are connected.

Referring now to Figure 6, a plurality of applicator devices 80 are shown. Each applicator device 80 has a needle passage 84 formed at a different location through such applicator device 80 . According to the apparatus and method of the present invention, a user will use each applicator device 80 in turn, one for each hemodialysis treatment. Needle passages 84 are at different locations to allow the user to insert the needle at different locations around the cannula insertion chamber 44. As shown in FIG. 7 , the needle passages 84 may extend at an angle rather than perpendicular to the surface of the applicator device 80 . In this arrangement, the needle penetrates port 47 in a manner that minimizes damage to the material of port 47. 8A and 8B show an embodiment of a dispenser for an applicator device. This dispenser preferably provides adequate spacing of the needle passages to allow dispensing around the cannulation site, which promotes healing between needle sticks and prolongs the life of the graft. Maintain the provided applicator devices in order.

In another embodiment, the applicator device includes a sheet, or sticker, as shown in FIGS. 9 and 10 and generally indicated at 90. This sticker 90 is a thin, generally rectangular element comprising a planar top surface 92, a bottom surface 94 and adhesive applied to the bottom surface of the sticker. Sticker 90 may be removably adhered to the surface of skin 30 to indicate a location for cannulation of vascular access graft 40. Sticker 90 defines a centrally located opening 96. The opening 96 as shown in Figure 9 has a generally elongated ovular shape. The shape of the opening 96 is not critical, but in practice the opening 96 should correspond to the features of the AVG for alignment of the sticker 90 with the AVG. In the depicted embodiment, the shape of the opening 96 in the sticker 90 corresponds to the size and shape of the cannula insertion chamber 44. Sticker 90 may include a soft, flexible material that allows the sticker to conform to any curves of the surface of skin 30 and AVG 40 beneath the skin. Accordingly, the curvature of the skin and any bumps under the skin can be changed without affecting the use of the sticker.

The bottom surface 94 of the sticker includes a layer of adhesive material for removably attaching the sticker to the skin 30 over the vascular access graft 40 . Many types of adhesives are suitable for use with sticker 90 as long as the adhesive allows secure adhesion of sticker 90 to the skin. The adhesive should also allow the sticker 90 to be easily removed after use. The adhesive is preferably an adhesive that is sensitive to the pressure applied to the bottom surface 94 of the sticker 90. A wide range of these adhesives are commercially available. In one embodiment, the edge portion of the bottom surface 94 of the sticker 90 may be free of adhesive to prevent portions of the sticker from adhering to the skin 30. This configuration provides a location for the user to hold the sticker 90 to remove the sticker from the skin 30. The adhesive material preferably does not leave any residue on the skin 30 when removed.

The sticker 90 is adhesive-coated and is large enough to accommodate the cannulation chamber 44 of the vascular access graft 40 as well as providing a secure bond between the sticker 90 and the skin 30. Area can be provided. In one embodiment, sticker 90 may have an outer perimeter that is greater than the outer perimeter of cannulation chamber 44 such that sticker 90 completely surrounds the chamber when placed over vascular access graft 40. Alternatively, only the edge area of the bottom surface 94 of the sticker 90 may be coated with adhesive material.

Sticker 90 may further include a protective backing removably attached to the bottom surface 94 of sticker 90 over the adhesive layer. A removable protective backing prevents sticker 90 from adhering to undesirable surfaces prior to use. Protective backings are well known in the art and include a variety of materials such as paper treated with a release agent such as silicone, or alternatively suitable materials such as polyethylene, polyvinyl chloride, etc. The removable protective backing may be the same size and shape as the sticker 90 or may be larger. In the above-described embodiment, the sticker 90 has a portion of the edge without adhesive, and the user can grasp that portion to easily remove the backing from the sticker 90.

In use, the protective backing is manually removed from the bottom surface 94 of the sticker 90 to expose the adhesive. The sticker 90 is then ready to be applied to the skin 30. Sticker 90 is positioned on the skin over AVG 40 such that opening 96 substantially surrounds cannula insertion chamber 44. Once positioned, pressure is applied to adhesively fit the sticker 90 to the skin 30 . Once secured to the skin 30 around the cannulation chamber 44 of the vascular access graft 40, the sticker 90 will allow the user to determine the location of needle insertion. Accordingly, sticker 90 provides an effective way to provide a means of indicating the location of cannulation of the AVG.

In another embodiment shown in FIGS. 13 and 14 , the sticker 90 may be made to separate when removed from the skin 30 . For example, a portion of the sticker 90 may be made of a material with low tear propagation resistance. With the adhesive sticking relatively strongly to this part of the sticker, the sticker becomes a part when removed from the surface. More specifically, when sticker 90 is removed from skin 30, some of the material comprising sticker 90 will remain on the skin. The portion of the sticker left on the skin is a mark such as a tick mark 98, which is easily visible to the human eye and indicates the needle insertion point of the underlying AVG 40. A subsequent sticker 90 leaves a tick mark 98 on the skin 30 at the next site for cannula insertion. In another embodiment shown in Figure 14, demarcation marks may remain on the skin when the sticker is removed, thereby providing an indication of the position of the cannulation chamber. A suitable sticker according to this embodiment is described in U.S. Pat. No. 4,268,983, the contents of which are hereby incorporated by reference in its entirety, and is an adhesive comprising a support sheet and a fragile and easily tearable film attached to the support sheet. Describes the gender label. If the label according to the '983 patent is removed from an article to which it has been applied, a portion of the fragile film containing the label will tear and remain attached to the substrate. U.S. Patent No. 5,358,281, incorporated herein by reference in its entirety, describes an adhesive label that leaves elements of the label on the surface, including a visible mark, when removed. It is understood that the marks left on the skin surface may be alphanumeric characters that spell words. U.S. Patent No. 4,121,003, incorporated herein by reference in its entirety, also describes the transfer of alphanumeric characters when removing a label, wherein the characters separate from the adhesive label itself when the adhesive label is separated from the surface and the surface to which the label was attached. Includes materials with low adhesion that partially remain in the

In another embodiment shown in Figure 12, the sticker 90 is unitary with no openings. A portion of the sticker 90 configured to represent the cannula insertion chamber 44 includes sections for identifying potential sites for cannula insertion. One section 102 of sticker 90 is removable. In use, sticker 90 is applied to skin 30 over AVG 40. A section 102 of the sticker over the cannula insertion site is peeled from the skin 30 surface. The exposed skin 30 is used as a site for needle insertion. U.S. Pat. No. 5,633,058, incorporated herein by reference in its entirety, describes a transparent printed insignia lightly anchored to a backing film that is stickered with a full-area colored layer that adheres well to the backing film and the printed insignia. The colored layer is coated with a self-adhesive composition.

An embodiment for use in combination with an applicator device for positioning the cannula insertion point of an implanted AVG is shown in FIGS. 15A and 15B and generally indicated at 110. This coupling includes a pair of circular flexible straps 112 for securing the applicator device 116 to a part of the user's body, which is the arm as shown in FIG. 16 . Applicator device 116 has grooves 114 at each end to receive straps 112. In use, applicator device 116 is positioned over cannulation chamber 44 as described above. Straps 112 hold the applicator device in place for subsequent cannulation. One advantage of this arrangement is that after hemodialysis and removal of the needle, the straps 112 press the applicator device 116 against the arm providing pressure to help stop bleeding.

Another embodiment of a device and method for guiding cannulation of an arteriovenous graft using straps 112 is shown in FIG. 17 . In this embodiment, straps 112 provide a means of positioning cannulation chamber 44 for subsequent cannulation. Each strap 112 has two notches 118 spaced circumferentially in the inner surface 120 . Notches 118 are configured to receive the ends of a pair of cannulation chambers 44 when placed over a patient's AVG 40. The straps 112 together show the ends of the cannulation chambers 44 to assist the user in identifying the location for cannulation insertion. The straps 112 serve to secure the cannula insertion chamber 44 and prevent any movement of the device. In this way, the device can be secured to the cannulation chamber at either end.

Referring now to FIG. 18 , another embodiment of an applicator device for determining a location for cannulation of a vascular access graft 40 is shown and generally designated 130 . In this embodiment, the applicator device 130 is a sleeve 132 for sliding over the arm. Sleeve 132 is made of flexible elastic fabric so that sleeve 132 is securely fastened to the arm when worn. The sleeve 132 defines a pair of circumferentially spaced openings 134 having a generally elongated oval shape. The shape of the openings 134 is not critical, but in practice the openings 134 should correspond to the shape or characteristics of the AVG for alignment of the openings with the AVG. In the depicted embodiment, the shape of the openings 134 in the sleeve 132 corresponds to the size and shape of the cannulation chamber 44.

In use, sleeve 132 is placed on the arm with openings above cannula insertion chamber 44. The user may then perform cannulation of the vascular access graft 40. In another embodiment, each opening 134 of sleeve 132 forms a pocket 136 with a layer of material adjacent skin 30 (FIG. 19). Pockets 136 are configured to receive an applicator device for use in positioning and cannulating the AVG (FIG. 20).

The devices and methods for cannulating vascular access grafts as described herein have many advantages, including providing a reliable means of enabling the user to perform hemodialysis while maintaining consistent and accurate access to the implanted graft site. has Using an external device to identify and localize the location of an implanted device reduces incorrect cannulation and promotes increased patency of vascular access grafts following surgical implantation in the body. Fewer missed needle insertion and cannula insertion errors result in damage to the implanted graft due to incorrect insertion of the cannula or inappropriate or repeated needle sticks attempting to "hit" the appropriate insertion site on the subcutaneous graft. , reduces the likelihood of destruction or displacing. The cumulative damage inflicted by repeated needle punctures weakens the graft wall and creates conditions for pseudoaneurysm formation. AVG maintains approximately 300 needle sticks per year. The devices and methods described herein, which provide needle rotation to evenly distribute needle damage across the entire length of the graft, help minimize or delay pseudoaneurysm formation.

The device tracks the position of the cannula insertion site to ensure proper needle rotation. A system or sequence designed to facilitate needle rotation facilitates proper needle rotation throughout the cannulation site area by maintaining compliance with the desired cannula sequence.

The present invention also improves the patient's or practitioner's ability to properly and accurately identify the placement of implanted vascular access grafts to ensure proper placement. Vascular access grafts can be visualized by conventional medical imaging means, including, for example, x-rays, magnetic resonance imaging, and/or computer-assisted tomography (CT).

Although the present invention has been shown and described in considerable detail with respect to only a few exemplary embodiments, a variety of embodiments can be found without departing substantially from the novel teachings and advantages of the present invention, particularly in light of the foregoing teachings. It should be understood by those skilled in the art that it is not intended to limit the invention to these embodiments, as modifications, omissions, and additions may be made. For example, the present invention is suitable for use in a number of vascular access devices and applications. Accordingly, we intend to apply all such modifications, omissions, additions and equivalents as may be included within the spirit and scope of the invention as defined by the following claims. In the claims, means-plus-function clauses are intended to label the structures described herein as performing the recited function and structural equivalents as well as equivalent structures. Thus, nails and screws may not be structural equivalents in the sense that nails use cylindrical surfaces to fasten wooden parts together, but in the context of fastening wooden parts, where screws use helical surfaces, nails and screws may be equivalent structures.

Claims (8)

A device for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft subcutaneously implanted in the body of a subject, comprising:
The arteriovenous dialysis access graft is a flexible conduit defining a longitudinal flow passageway and having a first end and a second end, the flexible conduit allowing blood to flow through the longitudinal flow passageway of the conduit. having a first end configured to connect to an artery of the subject and a second end configured to connect to a vein of the subject to flow from the first end to the second end, and a catheter defining a cannula insertion port. a cannula insertion chamber, the conduit extending through the cannula insertion chamber and configured to receive the dialysis needle when inserted through the cannula insertion port, the guiding device comprising:
an elongated body member having a first end, a second end, a longitudinal axis extending between the first end and the second end, and an interior surface, wherein the elongated body member is configured to have a longitudinal axis of the elongated body member. a planar base portion terminating with longitudinal edges parallel to the direction axis, and a leg extending from the longitudinal edges of the base portion in a direction transverse to the base portion and terminating at longitudinal edges. wherein the distance between the longitudinal edges of the base portion is equal to a lateral dimension of the cannula insertion chamber, and the base portion and legs are open longitudinally for receiving the cannula insertion chamber. Defines a channel (open longitudinal channel) - includes,
The legs align the inner surface of the base with the cannula insertion port to guide the position of dialysis needle insertion through the elongated body member and into the cannula insertion chamber. A device for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft subcutaneously implanted in a subject's body, wherein the elongated body member is configured to be secured adjacent the cannula insertion chamber to operatively engage the chamber. . delete According to claim 1,
of an arteriovenous dialysis access graft subcutaneously implanted in a subject's body, wherein the elongated body member has at least one passage opening that opens into the interior surface of the elongated body member to allow passage of a dialysis needle. A device for guiding cannulation with a needle. According to claim 1,
A device for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft subcutaneously implanted in a subject's body, wherein the cannulation chamber and at least a portion of the elongated body member comprise a magnetic material or a paramagnetic material. 1. A device for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft subcutaneously implanted in the body of a subject, comprising:
The arteriovenous dialysis access graft is a flexible conduit defining a longitudinal flow passageway and having a first end and a second end, the flexible conduit allowing blood to flow from the first end through the longitudinal flow passageway of the conduit. having a first end configured to connect to an artery of the subject and a second end configured to connect to a vein of the subject, and a cannula between the first end and the second end. a cannula insertion chamber defining an insertion port, the conduit extending through the cannula insertion chamber and configured to receive the dialysis needle when inserted through the cannula insertion port, the guiding device comprising:
an elongated tubular sleeve having a longitudinal axis, the sleeve defining an opening having longitudinal and lateral dimensions configured to be equal to the longitudinal and lateral dimensions of the cannulation chamber. do,
The sleeve is configured to receive the subject's body adjacent the cannulation chamber of the access graft such that the opening surrounds the cannulation chamber to guide the position of dialysis needle insertion into the cannula insertion port. , a device for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft implanted subcutaneously into the body of a subject. According to clause 5,
A device for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft subcutaneously implanted in the body of a subject, wherein the material of the sleeve is selected from film, paper, woven fabric or non-woven fabric. 1. A device for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft subcutaneously implanted in the body of a subject, comprising:
The arteriovenous dialysis access graft is a flexible conduit defining a longitudinal flow passageway and having a first end and a second end, the flexible conduit allowing blood to flow from the first end through the longitudinal flow passageway of the conduit. having a first end configured to connect to an artery of the subject and a second end configured to connect to a vein of the subject, and a cannula between the first end and the second end. a cannula insertion chamber defining an insertion port, the conduit extending through the cannula insertion chamber and configured to receive the dialysis needle when inserted through the cannula insertion port, the guiding device comprising:
an elongated body member having a longitudinal axis and an interior surface, the elongated body member comprising a base portion terminated with longitudinal edges, the distance between the longitudinal edges of the base portion being equal to a lateral dimension of the cannulation chamber. Same as -, and
an elongated tubular sleeve having a longitudinal axis, the sleeve defining a pocket having a longitudinal dimension and a lateral dimension configured to receive the elongated body member;
The elongated body member is positioned in the pocket of the sleeve to secure adjacent the cannula insertion chamber such that the inner surface of the base is aligned with the cannula insertion port to guide the insertion position of a dialysis needle. A device for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft subcutaneously implanted in a subject's body, configured to receive. As a kit,
at least one dialysis needle for accessing an arteriovenous dialysis access graft subcutaneously implanted in the body of a subject, the arteriovenous dialysis access graft being a flexible conduit defining a longitudinal flow passage and having a first end and a second end, wherein blood flows the first end configured to connect to an artery of the subject and the second end configured to connect to a vein of the subject to flow from the first end to the second end through the longitudinal flow passage of the conduit. A branch comprising the flexible conduit and a cannula insertion chamber defining a cannula insertion port, the conduit extending through the cannula insertion chamber and configured to receive the dialysis needle when inserted through the cannula insertion port. configured -;
dispenser; and
A plurality of elongated body members, each elongated body member having a longitudinal axis and an interior surface, the elongated body member including a base portion terminating in longitudinal edges, between the longitudinal edges of the base portion. The distance of is equal to the lateral dimension of the cannula insertion chamber,
The elongated body member is positioned in the cannula insertion chamber such that legs operatively engage the cannula insertion chamber to align the interior surface of the base with the cannula insertion port to guide the insertion position of a dialysis needle. Configured to be fixed adjacently,
Each elongated body member has at least one passage opening that opens into the inner surface of the elongated body member for passage of a dialysis needle, wherein at least one passage opening of the elongated body member is at least one passage opening of any other body member. Kit, located at a different location from the passage opening.

Images